Prosthetic devices such as heart replacement valves are generally manufactured in a non-sterile atmosphere. They are then placed in plastic bags and shipped in openable plastic boxes to the ultimate user who may be, for example a surgeon in a hospital. The boxes may be suitably provided with sponge rubber mats or the like to prevent damage to the prosthetic devices by reason of jarring action thereagainst.
In the hospital, the prosthetic device is removed manually from the box and from the bag in which it has been packed and is ultimately autoclaved. This autoclaving operation may sometimes take place in a container or it may, for example, take place in a rack. The autoclaving is usually effected in an area adjacent the operating room in which is performed the surgical procedure which results in the installation of the prosthetic device. The autoclaving operation takes care of sterilizing the prosthetic device but does not take care of degreasing the device nor of removing foreign substances as will further be discussed hereinbelow.
The prosthetic device when taken out of the autoclave is usually handled with sterile tongs or the like and is handed to a scrub nurse who may pick it up with a sterilized, gloved hand and who may then, in the case of a heart replacement valve, for example, drop it into a beaker containing a physiologic saline solution or a Ringers solution containing antibiotics and the like.
As a result of the above type of procedure, the prosthetic device is progressively sterilized but becomes increasingly covered by grease and other foreign material which is harmful to the acceptance of the prosthetic device in the environment into which it is to be placed. In this relatively dirty form, the heart replacement valve or other such prosthetic device is handed to the surgeon for implantation.
The "dirt" does not cause infection but leads to a number of other disadvantageous results. For example, this dirt may cause thrombosis or it may cause abnormal fibroplasia or it may possibly increase a subsequent tendency towards infection.